Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GET TESTED INTERNATIONAL AB
- Product type
- Drug Test Kit
- Model numbers
- EAN: 7340221701045, SKU: A-DR4, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Distribution without premarket approval/clearance.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
About This Product
Drug test kit designed to screen for four substances. It is sold as a medical device under Health & Personal Care products.
Why This Is Dangerous
Distribution without premarket approval or clearance means the product lacks regulatory authorization to be marketed in the United States. This can affect test validity and safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may be exposed to unapproved testing devices. The recall requires immediate stop-use to reduce potential regulatory and safety risks.
Practical Guidance
How to identify if yours is affected
- Verify brand: GET TESTED INTERNATIONAL AB
- Check product name: Drug Test Small (4 substances)
- Check model number: A-DR4
- Check Lot/Serial Number: All Lots
Where to find product info
Recall notice and FDA enforcement page for identifiers and instructions.
What timeline to expect
Not specified in the recall notice.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- File a complaint with the FDA if the company is unresponsive.
- Consider legal consultation for injury claims.
How to prevent similar issues
- Buy from reputable retailers and verify regulatory clearance before purchase.
- Check packaging for FDA clearance or premarket notification numbers.
- Monitor recalls from FDA and CPSC.
Documentation advice
Retain recall notice, photos of packaging, receipts, and correspondence with the manufacturer.
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Product Details
Model numbers: EAN 7340221701045; SKU A-DR4; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the US. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model: A-DR4 with EAN 7340221701045
- Lot/Serial Number: All Lots
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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